December ANDA Rush Is Largest Monthly Haul In Two Years
However, the month may be losing its influence over the US FDA's annual submission total.
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CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
US FDA reports another low tally of full approvals in October, but stakeholders are not worried given the agency's history of record-breaking totals year over year.
Approvals also plummeted, but US FDA remains on a record-breaking pace.